Pfizer announced yesterday the initiation of a phase 3 trial for its once-daily Janus kinase 1- (JAK1) selective inhibitor, PF-04965842, to evaluate the safety and efficacy of the drug for the treatment of moderate to severe atopic dermatitis (AD).
Pfizer announced yesterday the initiation of a phase 3 trial for its once-daily Janus kinase 1- (JAK1) selective inhibitor, PF-04965842, to evaluate the safety and efficacy of the drug for the treatment of moderate to severe atopic dermatitis (AD). AD, also commonly referred to as atopic eczema, is inflammation of the skin characterized by redness, itching, papulation, and crusting. This is the first trial in Pfizer’s JAK1 Atopic Dermatitis Efficacy and safety (JADE) global development program.
PF-04965842 is an oral small-molecule drug that selectively inhibits JAK1. The inhibition of JAK1 controls multiple cytokines involved in pathophysiology of AD including interleukin (IL)-4, IL-13, IL-31 and interferon gamma.
“By initiating this phase 3 program in atopic dermatitis, we hope to provide a new potential treatment option for people suffering with this condition,” said Michael Corbo, chief development officer, inflammation and immunology for Pfizer’s division of global product development, in a press release.
The phase 3 trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to determine the efficacy and safety of PF-04965842 in 375 patients aged 12 years and older, who have moderate to severe AD, over a period of 12 weeks. Trial participants will be randomly assigned to receive 200 mg or 100 mg of PF-04965842 once daily, or a placebo once daily. There will be a 4-week safety follow-up period, and the option to enter a long-term extension study (B7451015) at week 12.
The primary endpoints of the study are the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0/1 and 2-point improvement or greater, and the proportion of patients with at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) score. Key secondary endpoints include the pruritus numerical rating scale, the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) electronic diary, and safety measures (such as the incidence of treatment emergent adverse events and laboratory abnormalities).
This trial is set to begin concurrently with study B7451015 in North America, Australia, and Europe in 2018.
More on the study can be found on www.clinicaltrials.gov under the identifier NCT03349060.